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Coalition Commentary on Current Issues

First Round Victory in Protecting DTC Advertising

The AAAA Washington Office Head Reports
On Senate vote on DTC and related amendments
to FDA Authorization Bill

After weeks of hard-fought negotiations, U. S. Senate leaders have agreed to REMOVE proposed restrictions on the direct-to-consumer advertising of prescription drugs from the pending drug safety bill. The decision to end efforts to hamstring DTC ads came last night when the Senate incorporated industry-supported amendments into the FDA Revitalization Act. Final passage of the bill is expected today, May 9th.

Early versions of the bill had required a 2-year moratorium on ads for new prescription medications, pre-clearance of the ads by the FDA, and, most onerous of all, mandatory warnings in ads outlining cumbersome and detailed risks associated with a drug. These restrictions would have, in effect, ended most prescription drug advertising.

Senator Pat Roberts (R-KS), with support from Sen. Richard Burr (R-NC) and Sen. Tom Coburn (R-OK), led the effort to remove the restrictions. Sen. Ted Kennedy (D-MA), chair of the Health, Education, Labor and Pensions Committee, and ranking member, Sen. Mike Enzi (R-WY), facilitated the adoption of the Roberts amendment, after an unprecedented lobbying effort by AAAA and other industry groups.

Thanks to all of you who contacted your Senator to ask for support of the Roberts effort. Senators' offices reported a heavy volume of calls concerning the bill.

FIGHT MOVES TO THE HOUSE OF REPRESENTATIVES

Passage of the Senate bill is only the first step in action on the FDA Revitalization Act. The bill now moves to the House of Representatives, where it becomes pending business before the House Committee on Energy and Commerce. Observers predict an even more difficult fight to protect DTC advertising during House debate.

We will continue to update you on developments in this area and alert you when further help is needed. Meanwhile, thank you again for your efforts and your support.

Richard O’Brien
Executive Vice President
AAAA, Washington, DC
_______________________________ All the details on the bills and instructions on how to contact Senators are available on the AAAA website: http://www.aaaa.org/EWEB/Dynamicpage.aspx?webcode=LNDGA&key=b1e045aa-e4ff-441a-bafd-1ab41a3cc97d.

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